ISRCTN84775121已完成Unknown
Contact lens performance novel endpoints validation
Ocular Technology Group-International (OTG-i)0 个研究点目标入组 25 人开始时间: 2023年11月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •There are no requirements as to participant race or gender.
- •1. Age 18 to 35 years
- •2. Current daily disposable hydrogel or silicone hydrogel spherical contact lens wearer
- •3. Normal contact lens wearing characteristics as per Young modified questionnaire
- •4. Spectacle refraction:
- •4.1. Sphere: -6.00D to + 2.00D
- •4.2. Astigmatism: 0.00D to -0.75
- •5. Best corrected visual acuity of at least 20/25 in each eye
- •The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
排除标准
- •To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
- •The following are specific criteria that exclude a candidate from enrolment in this study:
- •1. Acute and subacute inflammation or infection of the anterior chamber of the eye
- •2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear
- •3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
- •4. Severe insufficiency of lacrimal secretion (dry eyes)
- •5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema)
- •6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
- •7. Any active corneal infection (bacterial, fungal, protozoal or viral)
- •8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
- •9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
- •10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
- •11. History of corneal refractive surgery
- •12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
研究者
相似试验
已完成
不适用
Performance evaluation of cosmetic contact lenses - a useability studyDesire to alter or enhance eye colourEye - Normal eye development and functionACTRN12611000526976Vision Science Co. Ltd.65
已完成
不适用
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed LensRefractive AmetropiaNCT01484054Johnson & Johnson Vision Care, Inc.103
尚未招募
Unknown
The effect of new contact lens disinfectant solution on the contact lens discomfortContatct lens discomfortEye - Diseases / disorders of the eyeACTRN12623001252606niversity of New South Wales30
已完成
不适用
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens WearersMyopiaRefractive ErrorAstigmatismHyperopiaNCT01912768Alcon Research362
已完成
不适用
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens WearersMyopiaAstigmatismRefractive ErrorHyperopiaNCT01912781Alcon Research112